Merck Filed Suit Contesting Government’s Attempt to Control Drug Prices
June 9, 2023
Posted by Frank Ciesla
Merck has filed suit contesting the government’s attempt to control drug prices for certain government programs. This case will likely end up in the Supreme Court in a couple of years. As I have proposed for years- we should adopt a Most Favored Nations approach. It would apply to all sales in the US – so benefit all Americans. Highly doubtful it can be successfully attacked in Court. Read more
Revisions to Special Focus Facility Program
November 8, 2022
Posted by Anjali Baxi
In October 2022, Centers for Medicare & Medicaid Services (CMS) made some significant changes to the Special Focus Facility (SFF) program that raise the bar for completion of the program and that increases enforcement actions for nursing homes that fail to demonstrate improvement.
The Affordable Care Act mandated that underperforming nursing homes undergo increased inspection and progressive enforcement actions through the SFF program. Sections 1819(f)(8) and 1919(f)(1) of the Social Security Act require CMS to conduct an SFF program which analyzes nursing homes that demonstrate persistent noncompliance with CMS regulations leading to a substantial quality of care. See 42 U.S.C. §§ 1819(f)(8), 1919(f)(1). The CMS SFF program requires the persistently poor performing facilities selected in each state to be inspected at least once every six months and that enforcement actions are taken when warranted. Despite the current SFF program and demonstrated improvement from certain facilities, CMS has found that some facilities remain on the program by failing to show the necessary improvement needed to graduate from the program. CMS has seen certain facilities graduate from the SFF program only to backslide into a non-complaint state, rendering the facility in question to be placed back on the SFF program. To combat this, CMS has authorized revisions to the SFF program to improve quality of care that residents living in a non-compliant facility receive. Additionally, because of CMS’ belief that staffing levels have a significant impact on quality of care, CMS is advising State Survey Agencies to consider a facility’s staffing level, in addition to its compliance history, when selecting candidates from their state for inclusion into the SFF program. Read more
April-July 2022 State Regulatory Developments
July 22, 2022
Posted by Anjali Baxi
Below are the most recent health care related regulatory developments as published in the New Jersey Register in April-July 2022: Read more
March 2022 State Regulatory Developments
April 12, 2022
Posted by Anjali Baxi
Below are the most recent health care related regulatory developments as published in the New Jersey Register in March 2022: Read more
February 2022 State Regulatory Developments
March 8, 2022
Posted by Anjali Baxi
Below are the most recent health care related regulatory developments as published in the New Jersey Register in February 2022: Read more
January 2022 State Regulatory Developments
March 8, 2022
Posted by Anjali Baxi
Below are the most recent health care related regulatory developments as published in the New Jersey Register in January 2022: Read more
Most Favored Nation
January 14, 2022
Posted by Frank Ciesla
Over the years I have written about the use of “Most Favored Nation” approach to the pricing of Drugs.
- Saga of Most Favored Nations
- Pharmaceutical Industry Challenges President Trump’s EO Adopting Most Favored Nation Approach
- Pharmaceutical Price Reduction Approaches
- Pharmaceutical Importations
- Most Favored Nations
- Prescriptions from Outside the US
- Pharmaceuticals
- Pharmaceutical Pricing: Update to May 17, 2018 Blog
- Pharmaceutical Pricing
Currently there is a nationwide preliminary injunction enjoining the Department of Health and Human Services from implementing the Most Favored Nation Rule. Given this preliminary injunction, the Most Favored Nation Model was not implemented on January 1, 2021 and will not be implemented without further rulemaking. The Trump administration started moving in that direction. It now appears that the Biden administration is rejecting that approach in favor of the government negotiating prices. What is not clear is what standard will be adopted and by whom as to how the approved price will be negotiated. As more details become available, we will comment.
October-December 2021 State Regulatory Developments
January 12, 2022
Posted by Anjali Baxi
Below are the most recent health care related regulatory developments as published in the New Jersey Register from October-December 2021: Read more
September 2021 State Regulatory Developments
October 12, 2021
Posted by Anjali Baxi
Below are the most recent health care related regulatory developments as published in the New Jersey Register in September 2021: Read more
August 2021 State Regulatory Developments
September 7, 2021
Posted by Anjali Baxi
Below are the most recent health care related regulatory developments as published in the New Jersey Register in August 2021: Read more
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